A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibiā¦ (NCT02197000) | Clinical Trial Compass
CompletedNot Applicable
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers
Israel23 participantsStarted 2014-11-11
Plain-language summary
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.
Who can participate
Age range18 Years ā 70 Years
SexFEMALE
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Inclusion Criteria:
* Women who carrier the BRCA 1\\2 mutation.
* No history of breast or ovarian malignancy.
* i. Baseline mammographic breast density is more than 10% OR ii. Baseline breast MRI with density or enhancement ā¤ 2.
* Age 18-70.
* Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule.
* Informed written consent must be signed according to ICH/EU GCP, before subject registration.
Exclusion Criteria:
* Women who have undergone preventive breast reduction.
* Breast imaging demonstrating a lesion suspected to be cancerous.
* Breast feeding or Pregnancy or planning to get pregnant.
* Known allergy to DIM and its ingredients.
What they're measuring
1
Changes in breast density compared to baseline
Timeframe: 0, 12 and 24 months following intiation